This is a Phase 3, randomized, open-label, multicenter, study in male and female pediatric subjects (2 years to \<18 years of age) with IDA, or felt by their clinician to be at risk of developing IDA. This study allows for enrollment of subjects with IDA regardless of etiology, except for CKD subjects (pediatric CKD subjects are being studied in a separate ferumoxytol protocol).
Male or female 2 years to <18 years of age at time of consent
Hemoglobin (Hgb) <11.0 g/dL AND
Transferrin saturation (TSAT) <20%
ferritin <100 ng/mL
Known hypersensitivity reaction to any component of ferumoxytol or iron sucrose
History of allergy to intravenous (IV) iron
History of ≥2 clinically significant drug allergies
Subjects with CKD (defined as eGFR of <60 mL/min/1.73 m2 or a requirement for chronic hemodialysis or peritoneal dialysis during Screening)
Parallel
ferumoxytol
DrugEach 20 mL single-use vial contains 17 mL of ferumoxytol that consists of iron at a concentration of 30 mg Fe/mL, coated with polyglucose sorbitol carboxymethylether and formulated with mannitol, at a concentration of 44 mg/mL, in a black to reddish brown sterile, aqueous, colloidal, isotonic solution
Iron sucrose
DrugEach mL contains 20 mg of elemental iron as iron sucrose in water for injection. The 5 mL single-use vial contains 100 mg of iron per 5 mL. The drug product contains approximately 30% sucrose (300 mg/mL).
Change in Hemoglobin from Baseline to Week 5
Proportion of subjects achieving a change in hemoglobin from Baseline to Week 5
Incidence of Treatment Emergent Adverse Events
Incidence of Treatment Emergent Adverse Events
Incidence of adverse events of special interest (AESI)
Incidence of adverse events of special interest (AESI) (hypotension and hypersensitivity)
Area Under the Curve (AUC)
Pharmacokinetic parameter: Area Under the Curve (AUC)
Clearance
Pharmacokinetic parameter: Clearance
Distribution
Pharmacokinetic parameter: Distribution
Elimination half-lives
Pharmacokinetic parameter: Elimination half-lives
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